Yunzhi as Dietary Supplement in Breast Cancer

Phase 4

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Yunzhi extract; Dietary Supplement: Placebo

• Registration Number: NCT00647075
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The purpose of this study is to assess the effects of a dietary supplement, the traditional Asian mushroom Yunzhi, as adjuvant in the treatment of patients with breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Status Verified: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-14
• Last Update Posted: 2010-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women with diagnosis of breast cancer
2. Undergoing adjuvant/neoadjuvant chemotherapy with either FEC, FAC, TAC, or EC + docetaxel combinations.
3. ≥ 18 years of age
4. Performance status: 0-2
5. Ability to provide written informed consent

Exclusion Criteria

1. Any prior history of yunzhi use
2. Use of other herbal remedies during the study duration
3. Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the participant a poor candidate for study participation
4. Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization)
5. Systemic use of progestins, androgens or other steroids (dexamethasone is allowed if used as antiemetic therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Yunzhi extract	Yunzhi extract 3.5 g/day
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Mean change in signs and symptoms from baseline measured by Visual Analogue Scale (VAS)	6 months

Secondary Outcome Measures

Name	Time	Method
Treatment adherence Clinical and laboratory (including RBC, WBC and platelets) adverse events Adherence to chemotherapy schedule EPO and blood transfusion needs	6 months

Trial Locations

Locations (2)

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain